Optical Coherence Tomography: Glatiramer in Clinically Isolated Syndrome or Early Relapsing Remitting Multiple Sclerosis (MS)

Multiple Sclerosis Clinical Trial

— OCTIMS  

Official title:

A Multicenter Longitudinal Cross-sectional Pilot Study, to Compare RNFL Thickness Measured by OCT After Treatment With Glatiramer or After no Treatment in Patients With CIS With or Without Optic Neuritis or With Early RRMS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00910598
• Other study ID #: OCT
• Status: Recruiting
• Phase: Phase 4
• First received: May 29, 2009
• Last updated: February 9, 2010
• Start date: September 2009
• Est. completion date: June 2012

Study information

• Verified date: February 2010
• Source: Amphia Hospital
• Contact: E.C.A.M. Sanders, MD
• Phone: +31 76 5258246
• Email: rsc[@]rsconsultancy.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

This is a study in patients with clinically isolated syndrome (CIS) and early relapsing remitting multiple sclerosis (RRMS) to assess the effects of glatiramer acetate (GA) subcutaneously on the condition of the optical nerve in comparison to no medicinal therapy during 12 months and to assess the use of Optical Coherence tomography (OCT), a non-invasive ophthalmological technique, in daily practice as an alternative to magnetic resonance imaging (MRI) scanning for follow-up of these patients.

Description:

Multiple sclerosis (MS) is a progressive and demyelinating disease of the central nervous system characterized by inflammation and neurodegeneration. It is characterized by an ongoing process of demyelination and axonal loss, even at the beginning of the disease course, which will result in brain atrophy. A first manifestation of clinical definite MS, is called a clinically isolated syndrome (CIS). Brain atrophy occurs even in patients with a CIS. Optic neuritis (ON) is a common feature of a CIS. The axons in the retina represent the most proximal part of the optic nerve which is devoid of myelin. Because the retina is part of the central nervous system (CNS), measurement of the Retinal Nerve Fiber Layer (RFLN) by Optical Coherence Tomography (OCT) offers the opportunity to visualize the unmyelinated axons of the CNS directly. OCT is a non-invasive method to measure the thickness of the optical layer. The thickness of the RNFL is reduced in MS patients with or without ON history.

Glatiramer acetate (GA), an immunomodulatory drug for RRMS and CIS, reduces brain atrophy and stimulates the production of brain-derived neurotrophic factor, which in turn could stimulate neuroregeneration.

In this pilot study we would like to assess the feasibility of OCT measurement in patient with CIS other than ON in the Dutch clinical setting and to assess the effect of GA on the RNFL and visual function in patients with CIS or in early relapsing remitting MS patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Age: 18 - 55 years

• Early relapsing remitting MS, defined as a disease course less than 3 years

• clinically isolated syndrome , defined as optic neuritis (ON) or other than ON

• Currently treated with glatiramer (GA) or currently not treated for MS

• Expanded disability status scale (EDSS) score 0-5

• Able and willing to provide written informed consent prior to enrolment

• Willing and able to comply with the protocol requirements for the duration of the study

Exclusion Criteria:

• Clinical definite multiple sclerosis with a disease course more than 3 years

• Primary progressive multiple sclerosis

• Secondary progressive multiple sclerosis

• Current use of any approved or investigational disease modifying agents for the treatment of MS other than GA.

• Neuromyelitis Optica (Devic's disease)

• Any condition that may interfere with the quality of the OCT scan: clouding of the media, i.e. cataract, pupil which are hard to dilate.

• Contra-indications for Copaxone ® as defined in the Summary of Product Characteristics (SPC) text

• Hypersensitivity to GA or mannitol

• Subject's inability to complete the study or if the subject is considered by the investigator to be for any reason, an unsuitable candidate for this study.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• glatiramer acetate
20 mg daily s.c. for 1 year

Locations

Country	Name	City	State
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	Maasland Ziekenhuis	Sittard

Sponsors (3)

Lead Sponsor	Collaborator
Amphia Hospital	Sanofi, TEVA Pharmachemie

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of OCT measurement in patient with CIS with or without optic neuritis or with early RRMS in the Dutch clinical setting		1 year	No
Secondary	Mean change in RNFL in both eyes determined by OCT at baseline, month 3, month 6, month 9, month 12		1 year	No
Secondary	Other ophthalmological parameters		1 year	No

External Links

•   Amphia Hospital Breda Netherlands